Application of quality systems to virology testing.

Abstract

1 d arily on the testing of the finished product as a means to etect products that had performance that fell outside of set pecifications. This early approach has since been replaced y more modern, and more effective, techniques, which are ased on quality assurance and quality system management in ddition to quality control procedures. These modern techiques emphasize the need for continuously improving the uality and consistency of IVD products at all phases of roduction (as well as during the design and development hases). The Quality Policy of Bayer HealthCare, Diagnostics Diision has been established to meet customers’ expectations n designing, producing and delivering IVD products and ervices. To assure the fulfillment of the Quality Policy a uality System has been put in place that meets the requirethan 34,000 employees work for Bayer HealthCare. The Diagnostics Division, with activities in more than 100 countries and sales in 2002 of EUR 2.04 billion, is one of the world’s market leaders in diagnostic systems for critical care analysis, diabetes, hematology, urine chemistry, immunology, clinical chemistry and nucleic acid analysis. The Diagnostics Division is composed of four different business segments that address the needs of three separate customer segments. The four business segments are laboratory testing (LTS), nucleic acid diagnostics (NAD), near patient testing (NPT) and self-testing (STS). LTS, with its corporate headquarter offices in Tarrytown, NY (USA), has manufacturing plants in Dublin (Ireland) and Walpole, MA (USA). LTS is involved in the development, manufacture and marketing of a portfolio of innovative and cost-effective autoents of the United State’s Food and Drug Administration’s FDA, 1996) Quality System Regulation (FDA, 1996) as ell as that of the international quality standards ISO 9001 International Standard ISO, 9001, 2000), EN 46001 (CEN mated systems for diagnostic laboratories. These systems, branded as the ADVIA® line, address the needs in the fields of hematology, immunodiagnostics, clinical chemistry and laboratory automation. Diseases such as cancer and disorders o t i